Kornimate/medical-research-clean huggingface dataset:
dpp iv inhibition facilitates healing of chronic foot ulcers in type 2 diabetes

Conditions: Chronic Foot Ulcers

Summary: a randomized versus placebo trial designed to evaluate the clinical and humoral effects of 4 months of vildagliptin on healing of chronic ulcers in type 2 diabetes.

the chronic foot ulcer is a leading cause of hospital admissions for people with diabetes in the developed world and is a major morbidity associated with diabetes, often leading to pain, suffering, and a poor quality of life for patients. chronic diabetic foot ulcers are estimated to occur in 15% of all patients with diabetes and precede 84% of all diabetes-related lower-leg amputations.the pathophysiology of chronic diabetic ulcers is complex and still incompletely understood, the most important predisposing factors being diabetic neuropathy and vasculopathy. both micro and macroangiopathy strongly contribute to development and delayed healing of diabetic wounds, through an impaired tissue feeding and response to ischemia. hif-1α and vegf, as well as the no production from inos, may contribute to limitation of hypoxic injury by promoting angiogenesis and wound healing. experimental and pathological studies suggest that suggest that he incretin hormone glucagon-like peptide-1 (glp-1) may improves vegf generation, and promote pancreatic islet viability through the up-regulation of hif1α. therefore, aim of this study is to evaluate the effect of the augmentation of glp-1, by inhibitors of the dipeptidyl peptidase iv (dpp-4), such as vildagliptin, on hif-1α, vegf and inos in diabetic chronic ulcers.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * oral hypoglycemic agents treatment * chronic foot ulcers * adequate blood circulation (perfusion) was assessed by a dorsum transcutaneous oxygen test \>30 -mmhg, anklebrachial index values \> 0.7 and \ 30 mmhg, or doppler arterial aveforms that were triphasic or biphasic at the ankle of the affected leg * written consensus exclusion criteria: * active charcot disease * ulcers resulting from electrical, chemical, or radiation burns * collagen vascular disease * ulcer malignancy * untreated osteomyelitis, or cellulitis * ulcer treatment with normothermic or hyperbaric oxygen therapy * concomitant medications such as corticosteroids, immunosuppressive medications, or -chemotherapy * recombinant or autologous growth factor products * skin and dermal substitutes within 30 days of study start * use of any enzymatic debridement treatments * pregnant or nursing mothers

Keywords: type 2 diabetes healing foot ulcers vildagliptin
elderly cancer patients, safety and quality of life under immunotherapies

Conditions: Advanced or Metastatic Melanoma; Advanced or Metastatic NSCLC

Summary: the co-primary objectives will be to assess the safety and quality of life under treatment.

the co-primary objectives will be to assess the safety and quality of life under treatment. secondary objectives will be evaluations of geriatric data modifications under treatment, efficacy (progression-free survival and overall survival), correlation between toxicity and efficacy, and comparison of the safety profiles between various immunotherapy regimens. another secondary objective will be the comparison between patients and clinicians symptom reporting. the investigators will also perform a pharmacokinetics analysis on pd1-monoclonal antibodies to improve the understanding of pd-1 inhibitors pharmacokinetics for the elderly population. finally, toxicity and efficacy will be compared to immunological parameters such as the description of tumor infiltrating lymphocytes, markers of immunosenescence and inflammation.

Eligibility criteria:
inclusion criteria: * patients eligible to start a treatment including immune checkpoint inhibitors (nivolumab, ipilimumab, pembrolizumab, and so on...) * diagnosis of advanced or metastatic melanoma or nsclc (all treatment lines will be allowed) * age ≥ 70 years * having personally signed and dated informed consent * patient affiliated to the ''national security'' regimen or beneficiary of this regimen exclusion criteria: * immune checkpoint inhibitor therapy initiated before study enrolment * concomitant participation in other investigational clinical trials involving an immune checkpoint inhibitor * immune checkpoint inhibitor treatment in a context of other solid tumours * immune checkpoint inhibitor treatment in a context of haematological malignancies * being unable or unwilling to comply with the requirements of the protocol, as assessed by the investigator * patient in urgency situation, adult under legal protection, or unable to give his consent

Keywords: elderly cancer patients immunotherapies
nirs directed optimal cerebral perfusion pressure on the outcome of aneurysmal subarachnoid hemorrhage patients

Conditions: Optimal Cerebral Perfusion Pressure on the Outcome of aSAH Patients

Summary: objectives: to investigate the impact of nirs directed optimal cerebral perfusion pressure on the outcome of asah patients. study design: a multicenter, single-blinded, randomized controlled trial. setting: departments of critical care medicine of tertiary hospitals in china. patients: 150 asah patients (≥ 18 years old) who admitted to icu (predicted icu duration time ≥ 24 hours) intervention: patients with asah will be randomly divided into the control group and the intervention group. the control group will follow the sah guidelines. the intervention group will be given continuous nirs and invasive blood pressure monitoring at same time. the correlation curve between the brain oxygenation index or the brain hemoglobin index (ori/thx) and the blood pressure will be obtained through continuous monitoring. according to the correlation curve, the optimal blood pressure will be determined which provides the optimal cpp. then the goal of blood pressure (within 5 mmhg of cppopt) will be maintained as the target of blood pressure management for the intervention group during icu stay. primary outcome: neurological prognosis (gcs score，gos score, and nihss score when discharge from icu; gos score at 6 months), etc. predicted duration of the study: 2 years.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * admitted to icu because of asah. * predicted to stay in icu ≥ 24 hours * provide written informed consent. exclusion criteria: * unable to perform nirs monitoring because of anatomic factors; * patients with severe organ failure; * in addition to aneurysmal subarachnoid hemorrhage, there are other serious intracranial diseases (intracranial infection, cerebral hemorrhage, cerebral infarction, brain trauma, other patients after intracranial surgery); * patients with carotid plaque or thrombus; * patients with severe intracranial pneumatosis after craniotomy.
a study of the elopement prevention and safety training program

Conditions: Elopement; Autism Spectrum Disorder

Summary: the purpose of this study is to demonstrate the feasibility of the elopement prevention safety (epst) program in children with autism spectrum disorder (asd) who have engaged in eloping. this is a program created by the behavior treatment clinics to help caregivers come up with a safety plan to prevent their children from running away or wandering off.

a large number of children with autism spectrum disorder (asd) have a current or past history of elopement. for parents of a child with asd, having their child go missing is potentially dangerous and far more likely compared to typically developing children. this behavior interferes with household routines, engenders vigilance, and restricts the family's participation in their community. such restrictions contribute to the family's isolation and hinders development of community supports. elopement can result in injuries and deaths of children with asd.

Eligibility criteria:
inclusion criteria: 1. males and females, ages 4 to 12 inclusive 2. diagnosis of asd as determined by clinical interview and supported by standardized measures (i.e., autism diagnostic observation schedule-2, vineland, stanford-binet v) 3. engages in elopement in the form of bolting or wandering, as determined by structured interview 4. a caregiver who expresses a willingness to participate in treatment and complete baseline/outcome assessments. exclusion criteria: 1. unmanaged psychopathology or problem behavior other than elopement that warrants immediate clinical care, determined by clinical interview and aberrant behavior checklist (abc) 2. child and family currently in therapy that is likely to be redundant with the treatment program or interfere with proposed treatment 3. presence of both of the types of elopement under investigation (i.e., both bolting and wandering).
transarterial radioembolization (tare) in colorectal metastasis of liver

Conditions: Transarterial Radioembolization

Summary: radioembolization is an established treatment option for patients with unresectable primary and secondary liver tumors. microspheres containing 90y are injected intraarterially to deliver a high radiation dose to the tumors. despite of our knowledge on the effectiveness of 90y glass microspheres in the treatment of hcc, literature data on the treatment of metastatic colorectal cancer (mcrc) patients with 90y glass microspheres is limited. in the recent eanm guideline variable healthy liver doses are recommended for patients with mcrc with an effective tumor dose recommendation based on a study with limited number of patients. primary objectives; investigate effective tumor dose and safe healthy liver dose in radioembolization for colorectal cancer liver metastasis using multicompartment dosimetry secondary objectives; investigate dose-response and dose-toxicity relationships, time to progress, concordance between pretreatment and posttreatment dose calculations.


Eligibility criteria:
inclusion criteria: * over 18 years old * histopathologically proven colorectal cancer diagnosis * treated with radioembolization for liver metastases with y90 glass microspheres in lobar or segmental fashion * have follow-up data at least 6 months after radioembolization exclusion criteria: * no pet-ct, ct or mr of the liver within last 6 weeks prior to radioembolization. no pet-ct, ct or mr of the liver 2-4 months after radioembolization poor image quality previous local treatment or surgery for the liver
impact of positive & negative lens-induced defocus on contrast-sensitivity in myopic & non-myopic adults

Conditions: Myopia

Summary: examines the influence of lens-induced defocus on contrast sensitivity-a crucial aspect of visual performance.each participant experiences both positive and negative defocus through different lenses, with measurements taken for contrast sensitivity using the pelli-robson chart. outcomes are evaluated at baseline, 2 weeks, and 4 weeks to understand the effect of defocus over time.

additional data on symptoms like visual fatigue and computer vision syndrome are gathered using the visual fatigue questionnaire (vfq) and the computer vision syndrome questionnaire (cvs-q), respectively. this study's findings could be instrumental in refining optical treatments, offering insights into how defocus impacts visual function across refractive conditions. results may ultimately benefit optometric practices by guiding lens prescriptions for improved contrast sensitivity and quality of life for myopic and non-myopic individuals alike.

Eligibility criteria:
inclusion criteria: * adults aged 18 to 50 years. * participants with a confirmed diagnosis of myopia or non-myopia. * best corrected visual acuity of 20/30 or better. * no history of ocular surgery or significant ocular disease. * informed consent was obtained. exclusion criteria: * individuals with a history of systemic diseases affecting vision (e.g., diabetes, hypertension). * presence of binocular vision anomalies or strabismus. * pregnant or nursing women. * any current use of medications affecting visual function (e.g., medications causing visual side effects).
stress reduction in the prevention of left ventricular hypertrophy

Conditions: Left Ventricular Hypertrophy; High Blood Pressure

Summary: this study evaluated the effect of stress reduction by transcendental meditation (tm) on left ventricular mass compared to a health education control group in pre-hypertensive or hypertensive african-american adults over a six-month intervention period.

left ventricular hypertrophy (lvh) is an independent risk factor for cardiovascular disease (cvd). african americans have higher rates of lvh and cvd than whites. substantial evidence indicates that psychological stress contributes to lvh. this randomized controlled trial evaluated the effect of stress reduction with the transcendental meditation (tm) technique on left ventricular mass (lvm) in hypertensive african-americans. hypertensive african american men and women were tested at baseline for left ventricular mass index (lvmi) by m-mode echocardiography, blood pressure, lifestyle and behavioral factors. subjects were randomly assigned to either tm or health education (he) control. after six months intervention, 86 subjects were posttested on all outcomes. data were analyzed for between-group and within-group differences.

Eligibility criteria:
inclusion criteria: self-identified african-american men and women ages, 20-75 years old, with either prehypertension (systolic blood pressure (sbp) of 120-139 mm hg and/or diastolic blood pressure (dbp) of 80-89 mm hg), stage-1 hypertension (sbp of 140-159 mm hg and/or dbp of 90-99 mm hg) or stage-2 hypertension (sbp of 160-179 and/or dbp of 100-109 mm of hg), with or without antihypertensive medications - exclusion criteria: patients with a history of stroke, transient cerebral ischemic attack, congestive heart failure, myocardial infarction, angina pectoris or with significant ecg abnormalities, major psychiatric or behavioral disorder such as alcoholism (\> 28 drinks per week) -

Keywords: left ventricular mass meditation stress reduction
extension in as: sustainability of benefits, safety and tolerability

Conditions: Spondylitis, Ankylosing

Summary: this 3-year extension study aims at making available the treatment with secukinumab in prefilled syringes (pfs) to patients with ankylosing spondylitis who took part in phase iii study cain457f2305, defined as "core study", as well as to generate additional data on the sustainability of clinical benefits, safety and tolerability during long-term administration of secukinumab.


Eligibility criteria:
inclusion criteria: patients having completed the "core study" cain457f2305, indication for treatment extension. -- exclusion criteria: history of hypersensitivity to secukinumab or to any drug of similar chemical classes, use of any investigational drug other than secukinumab during the "core study" cain457f2305.

Keywords: ain457, ankylosing spondylitis, chronic inflammatory disease, inflammatory back pain, pfs, pre-filled syringe, secukinumab, self-injection
the effect of olive oil on diaper rash

Conditions: Diaper Rash; Olive Oil

Summary: objective: diaper rash is an irritating, common skin problem in newborns and young children and occurs in the skin rubbed by wet diapers and in the armpits due to heat, moisture and irritation. this experimental study was planned to investigate the effect of olive oil use on the healing of diaper rash in infants with first-degree diaper rash undergoing treatment in an infant ward. methods: the study conducted between september 2020 and december 2020 included 37 infants aged 0-24 months who were treated for any reason in the infant clinic of a medical school and had first-degree rash. the infants in the experimental and control groups were "treated with olive oil and x brand cream" respectively. the x brand cream and the effects of olive oil and x brand cream use on the improvement of diaper rash were compared.


Eligibility criteria:
inclusion criteria: * having a first-degree diaper rash * being 0-24 months old * having the family's consent indicating that they allow their child to be included in the study exclusion criteria: * the baby's having anorectal congenital anomaly * the baby's having an obstacle to the application of olive oil (allergy, etc.) * having a second-degree or third-degree rash
a pilot study evaluating the safety and effectiveness of a new pleural catheter for the medical management of symptomatic, recurrent, malignant pleural effusions

Conditions: Malignant Pleural Effusions

Summary: the purpose of this study is to determine whether a new catheter is safe and effective in treating malignant pleural effusions.


Eligibility criteria:
inclusion criteria: 1. subject is ≥ 18 years old. 2. subject has a symptomatic malignant pleural effusion requiring intervention. for an effusion to be defined as malignant, at least one of the following must be true: * there is histocytological confirmation of pleural malignancy * the effusion is an exudate (as per light's criteria) in the context of histocytologically proven malignancy elsewhere, with no other clear cause for fluid identified 3. subject has a history of at least one ipsilateral pleural effusion causing dyspnoea that responded to thoracentesis where the lung expanded and the dyspnoea was relieved. 4. subject is willing and able to provide written informed consent. 5. subject is willing and able to meet all study requirements, including attending follow-up visits or receiving trial-related telephone calls. 6. there is sufficient fluid on thoracic ultrasound to allow safe insertion of an indwelling pleural catheter 7. negative pregnancy test if appropriate exclusion criteria: 1. subject has significant trapped lung (\>20%), or a proximal bronchial obstruction which is likely to lead to trapped lung. 2. subject has a karnofsky score of less than 50, or a who/ecog performance status of 3\* or more. 3. subject is pregnant, planning to become pregnant, or is lactating. 4. subject has a history of empyema. 5. subject has a history of chylothorax. 6. subject has an uncorrected coagulopathy. 7. subject is allergic to device materials. 8. subject has evidence, in the opinion of the chief investigator, of either on-going systemic or pleural infection. 9. subject has had a lobectomy or pneumonectomy on the side of the effusion. 10. subject has undergone a previous attempt at pleurodesis which has failed. 11. subject has previously been diagnosed with a serious immunodeficiency disorder. 12. subject has bilateral pleural effusions, with both being at least moderate in size (greater than 1/3 of the hemithorax on chest x-ray). 13. subject has evidence of fluid loculation such that attempts at pleurodesis are likely to be futile. 14. subject has a mediastinal shift of ≥2cm toward the side of the effusion. 15. subject is receiving concurrent intrapleural chemotherapy or radiation therapy to the ipsilateral chest. 16. subject has any clinical condition, diagnosis, or social circumstance that, in the opinion of the chief investigator, would mean participation in the study would be contraindicated. 17. subject has no access to a telephone 18. no details of blood values (full blood count, clotting screen, urea and electrolytes, liver function) from within the last 10 days \* patients who have a performance status of 3 may be considered for the trial if the removal of their fluid would likely improve their performance score by 1 or more.
genetic polymorphisms of mannan-binding lectin (mbl)and serum levels of mbl in patients with endometriosis

Conditions: Endometriosis

Summary: the purpose of the study is to investigate the possible association between low levels of mbl and the development of endometriosis

endometriosis is a chronic, inflammatory disease, affecting approximately 10% of the female population. the pathogenesis of endometriosis is still unclear, but several studies have indicated that the immune system is involved. it has been suggested that endometriosis should be considered an autoimmune disease, considering the findings of elevated levels of cytokines, decreased cell apoptosis, increased incidence of autoantibodies and a higher frequency of other autoimmune diseases in endometriosis patients. mbl participates in the innate immune defence by activating complement on the surfaces of microorganisms, but several studies have suggested that mbl is also involved in autoimmune diseases. the individual mbl level is highly variable due to a number of polymorphic sites in the structural gene and in the promoter region, and approximately 12 % of the normal population have very low serum mbl levels (\<100 ng/ml). the possible association between mbl and endometriosis has been investigated in two small studies, in which no association was found. the aim of the present study is to investigate the prevalence of individuals with low serum levels of mbl and with genotypes associated with low mbl production in a larger group of endometriosis patients.

Eligibility criteria:
inclusion criteria: * histologically verified endometriosis * asrm stage 2-4 exclusion criteria: * pregnancy * actual treatment with gnrh analog * autoimmune diseases

Keywords: endometriosis mannan-binding lectin immunology
mycobacterium w in patients with severe sepsis

Conditions: Sepsis

Summary: recent evidence suggests that sepsis continuum includes an immune paralytic state, which may play a significant role in sepsis. mycobacterium w by its tlr4 agonist activity may help in restoring immunity, thereby improving outcomes in patients with severe sepsis. in this randomized trial, the investigators propose to evaluate the efficacy of mw in patients with severe sepsis.


Eligibility criteria:
inclusion criteria: patients with severe sepsis within 48 hours of first organ dysfunction * cardiovascular system dysfunction: systolic blood pressure ≤90 mm hg or the mean arterial pressure ≤70 mm hg for at least one hour despite adequate fluid resuscitation or the use of vasopressors to maintain a systolic blood pressure or mean arterial pressure of \>90 and \>65 mm hg, respectively * renal dysfunction: urine output \<0.5 ml/kg/hour for two consecutive hours despite adequate fluid resuscitation * respiratory system dysfunction: pao2/fio2 ≤300 or ≤250 if lung sepsis * hematologic dysfunction: platelet count \<100,000/mm3 or decrease by 50% in the three days preceding enrollment * unexplained metabolic acidosis: ph ≤7.30 exclusion criteria: * pregnancy * gram-positive culture * only fungal infection as source of sepsis * patients who received cardiopulmonary resuscitation * those on immunosuppressive therapy * those unwilling to provide informed consent